Regulation made simple thanks to Matrix Mind AI chatbot
Ask any complex question about regulation & standards in EU and the USA and get an accurate answer.
Core Matrix Mind Features
AI isn’t the future of regulatory affairs — it’s the now. Empower Regulatory & Quality teams with AI-driven guidance, automation, and compliance intelligence.
Stay up to date on every standardOur team of regulatory affairs specialists makes sure that Matrix Mind always uses the latest version of all FDA and EU / MDR standards.
Import standards that really matter for your deviceOur AI will automatically adjust its answers based on the standards that are relevant for your device. Remove the guess work, Matrix Mind knows what matters
Share your project with your teamEach project will be accessible by your team so that you all share the same knowledge. Matrix Mind will be the common source of truth accross your company
Control your data in a secured environment placeYour data is not used to train any LLM nor is it stored by third party provider. Once the answer is provided, all content is deleted forever on the LLM side
Keep asking until you know everythingOnce you get the first answer from Matrix Mind, you can follow up with specific questions to get more insights. Answers will get even better
Unlimited usageMatrix Mind usage is unlimited, it's your regulatory assistant available 24/24h and 7/7 days.
What Sets Us Apart
The first AI chatbot dedicated to MedTech regulatory & engineering experts
Domain-Specific Accuracy
Matrix Mind
ChatGPT
Questions related to widespread standards (e.g. ISO 13485)
Questions related to industry specific standards
Use of the last updated standards
Control over the standards used to provide the right answers
Device-Specific Accuracy
Ability to add technical documents on a device to improve context
Ability to add relevant standards for a specific device to improve context
Transparency
Reference and quotations of source of truth
Risk of hallucinations on complex questions
Data security
Zero data retention inside the LLM
Use of private data to train the model
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Matrix One is trusted by 500+ SxMD & Medical Device Companies
The first AI chatbot dedicated to MedTech regulatory & engineering experts
Matrix Mind
ChatGPT
Awareness of your current project context
Regulatory compliance checking against your standards (ISO 14971, IEC 62304, EU MDR…)
⚠️
Navigates across all your project items (requirements, risks, tests, design inputs/outputs)
Answers grounded in your actual project data — not generic knowledge
Generates risks, requirements, test cases & mitigations aligned to your design
Traces links between requirements, risks, and test cases automatically
Gap analysis against regulatory standards using your Matrix project data
Keeps your proprietary data secure — no training on your inputs
Built-in knowledge of FDA, EU MDR, ISO, and IEC standards
⚠️
Works inside your requirements management workflow — no copy-paste
Multi-project awareness across your entire product portfolio
Zero data retention inside the LLM
Matrix Mind
Awareness of your current project context
Regulatory compliance checking against your standards (ISO 14971, IEC 62304, EU MDR…)
Navigates across all your project items (requirements, risks, tests, design inputs/outputs)
Answers grounded in your actual project data — not generic knowledge
Generates risks, requirements, test cases & mitigations aligned to your design
Traces links between requirements, risks, and test cases automatically
Gap analysis against regulatory standards using your Matrix project data
Keeps your proprietary data secure — no training on your inputs
Built-in knowledge of FDA, EU MDR, ISO, and IEC standards
Works inside your requirements management workflow — no copy-paste
Multi-project awareness across your entire product portfolio
Zero data retention inside the LLM
ChatGPT
Awareness of your current project context
Regulatory compliance checking against your standards (ISO 14971, IEC 62304, EU MDR…)
⚠️
Navigates across all your project items (requirements, risks, tests, design inputs/outputs)
Answers grounded in your actual project data — not generic knowledge
Generates risks, requirements, test cases & mitigations aligned to your design
Traces links between requirements, risks, and test cases automatically
Gap analysis against regulatory standards using your Matrix project data
Keeps your proprietary data secure — no training on your inputs
Built-in knowledge of FDA, EU MDR, ISO, and IEC standards
⚠️
Works inside your requirements management workflow — no copy-paste
Multi-project awareness across your entire product portfolio
Zero data retention inside the LLM